Back to resultsBrivaracetam to Reduce Neuropathic Pain in Chronic Spinal Cord Injury
Primary Purpose
Spinal Cord Injuries
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Brivaracetam
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Spinal Cord Injuries
Eligibility Criteria
Inclusion Criteria:
- Spinal cord injury (SCI)
- Participants must have completed inpatient rehabilitation and are living in the community
- Participant who have severe below-level neuropathic pain (daily average 9/10 or 10/10)
- Participants must have tried and failed to achieve adequate pain relief with the use of other drugs (i.e treatment failed to decrease their pain below a level of 9) and can continue to take spasmolytics, pregabalin, gabapentin, and opioids in unchanged dosing throughout the trial
Exclusion Criteria:
- Pprogressive myelopathy secondary to posttraumatic cord tethering
- Syringomyelia
- Brain injury limiting the ability to follow directions
- Pregnancy or lactation
- Epilepsy
- Impaired liver or renal function
- Contraindications to brivaracetam or pyrrolidine derivatives including allergy, or contraindications to MRI including retained bullet fragments, noncompatible metal implants, and implanted devices such as baclofen pumps
Sites / Locations
- Swedish Hospital
- University of Minnesota School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Brivaracetam Group
Control Group
Arm Description
Participants in this arm will receive the investigational drug, Brivaracetam.
Participants in this arm will receive a placebo.
Outcomes
Primary Outcome Measures
Change in Brief Pain Inventory
The Brief Pain Inventory (BPI) contains 11 numeric rating scales that measure pain intensity and the effect of the pain on a participant's ability to function during various activities of daily living. Each of the 11 scales is rated from 0 (no pain/does not interfere) to 10 (severe pain/completely interferes). Total scores range from 0-110, with higher scores indicating greater pain and interference on daily activities.
Change in Satisfaction with Life Scale (SWLS)
The satisfaction with life scale contains 5 items designed to measure global cognitive judgments of life satisfaction. Each of the 5 items is rated on a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree). Total scores range from 5 to 35, with higher scores indicating greater satisfaction with life.
Secondary Outcome Measures
Change in Periaqueductal Gray Activity
Periaqueductal gray activity is measured by fMRI (functional magnetic resonance imaging). Outcome is reported as the change in bold signal (a unitless measure) in the targeted area.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04379011
Brief Title
Brivaracetam to Reduce Neuropathic Pain in Chronic Spinal Cord Injury
Official Title
Brivaracetam to Reduce Neuropathic Pain in Chronic SCI: A Pilot Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Spinal cord injury (SCI) is associated with severe neuropathic pain that is often refractory to all pharmacological intervention. Preliminary data suggest brivarecetum is a mechanism-based pharmacological intervention for neuropathic pain in SCI. This randomized, placebo-controlled pilot clinical trial will assess feasibility of a 3-month treatment course with brivarecetum.
Detailed Description
The investigations will assess changes in pain intensity and periaqueductal gray hyperactivity. Baseline periaqueductal gray hyperactivity and microRNA levels will be measured as potential biomarkers of response to treatment. These preliminary findings will be used to design larger clinical trials to establish efficacy of brivarecetum to treat neuropathic pain in SCI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brivaracetam Group
Arm Type
Experimental
Arm Description
Participants in this arm will receive the investigational drug, Brivaracetam.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Participants in this arm will receive a placebo.
Intervention Type
Drug
Intervention Name(s)
Brivaracetam
Other Intervention Name(s)
Briviact
Intervention Description
Escalating brivaracetam dose to 150 mg twice daily for 3 months
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo twice daily for 3 months
Primary Outcome Measure Information:
Title
Change in Brief Pain Inventory
Description
The Brief Pain Inventory (BPI) contains 11 numeric rating scales that measure pain intensity and the effect of the pain on a participant's ability to function during various activities of daily living. Each of the 11 scales is rated from 0 (no pain/does not interfere) to 10 (severe pain/completely interferes). Total scores range from 0-110, with higher scores indicating greater pain and interference on daily activities.
Time Frame
baseline, 3 months
Title
Change in Satisfaction with Life Scale (SWLS)
Description
The satisfaction with life scale contains 5 items designed to measure global cognitive judgments of life satisfaction. Each of the 5 items is rated on a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree). Total scores range from 5 to 35, with higher scores indicating greater satisfaction with life.
Time Frame
baseline, 3 months
Secondary Outcome Measure Information:
Title
Change in Periaqueductal Gray Activity
Description
Periaqueductal gray activity is measured by fMRI (functional magnetic resonance imaging). Outcome is reported as the change in bold signal (a unitless measure) in the targeted area.
Time Frame
baseline, 3 months
Other Pre-specified Outcome Measures:
Title
miRNA in Treatment Group
Description
Outcome reported as the mean number of copies of the target miRNA at baseline.
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Spinal cord injury (SCI)
Participants must have completed inpatient rehabilitation and are living in the community
Participant who have severe below-level neuropathic pain (daily average 9/10 or 10/10)
Participants must have tried and failed to achieve adequate pain relief with the use of other drugs (i.e treatment failed to decrease their pain below a level of 9) and can continue to take spasmolytics, pregabalin, gabapentin, and opioids in unchanged dosing throughout the trial
Exclusion Criteria:
Pprogressive myelopathy secondary to posttraumatic cord tethering
Syringomyelia
Brain injury limiting the ability to follow directions
Pregnancy or lactation
Epilepsy
Impaired liver or renal function
Contraindications to brivaracetam or pyrrolidine derivatives including allergy, or contraindications to MRI including retained bullet fragments, noncompatible metal implants, and implanted devices such as baclofen pumps
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie Morse, DO
Organizational Affiliation
University of Minnesota
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Scott Falci, MD
Organizational Affiliation
Swedish Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swedish Hospital
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
University of Minnesota School of Medicine
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Brivaracetam to Reduce Neuropathic Pain in Chronic Spinal Cord Injury
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